1. business and industrial
2. pharmaceutical industry

Survey of Finnish
vendors serving ­
the pharmaceutical
industry
What is required for
business success?
2
Authors
Marjut Ranki-Pesonen, MD, PhD
Esa Soppi, MD, PhD, MBA
Medical Interscience Talents M.I.T. Consulting Ltd.
Publisher
Culminatum Innovation Oy Ltd, September 2012
Layout
Mats Vuorenjuuri / Unikuva
ISBN
978-952-93-1071-5 (paperback)
978-952-93-1072-2 (PDF)
Culminatum Innovation Oy Ltd seeks to improve the international
­competetiveness and attractiveness of the Helsinki Region.
The Verkkovoimaa -project supports networking and internationalization among
expert service companies in the life science sector. Operations are funded by the
Centre for Economic Development, Transport and the Environment for Uusimaa,
the European Social Fund, the companies participating in internationalization
programmes, and the cities of Helsinki, Espoo, Vantaa and Kauniainen.
3
Executive summary
This survey identified 43 pharmaceutical outsourcing vendor companies whose range of
services is distributed over the entire value chain
of pharmaceutical R&D. Nonclinical contract research including disease models is provided by
six vendors, whereas 13 provide clinical trial services and nine companies are engaged in contract
manufacturing. The rest of the companies are active in biostatistics, bioinformatics, and diverse
special services. The majority of the vendors are
either microenterprises or small enterprises. Only
eight are medium-sized or large enterprises employing more than 50 people. The companies
are often spin-offs of university groups and are
characterized by a high level of know-how. The
large enterprises are established companies with
a longer life-span or the result of recent consolidations. The turnover of the three largest companies accounts for 58% of the entire business
volume (€94 M out of €162 M).
The global pharma outsourcing business has undergone constant change during the past decade,
reflecting the challenges of and trends in the
pharmaceutical field. Clinical research organizations (CROs) actively form mergers and strategic
partnerships with their pharma clients, becoming
continuously larger and better able to offer an
increasing service portfolio. Yet smaller pharma
clients are best served by outsourcing vendors of
equal size. In addition, there are niche markets
for specialized services. In Finland, the number of
clinical trials has seen a significant decrease during recent years, which is reflected in the declining turnover of CROs engaged in clinical trials.
According to the survey, the main challenges facing outsourcing companies are:
1) Credibility issues owing to their small size.
Pharmaceutical companies are unwilling to
take the risk of outsourcing tasks to companies where critical skills lie in the hands of
only a few persons.
2) Unless the service provided by a vendor is absolutely unique, pharma clients wish to acquire a range of services from the vendors
they approve. This is because the evaluation
process involved is lengthy.
3) Lack of marketing power.
4) Limited resources in business management.
The interviews revealed the following keys to
success:
1) A service product built on solid core competence that withstands critical assessment.
2) A product that has undergone conceptualization to deliver the intended benefits to customers.
3) Flexibility in the content of service-provision,
including accessory know-how. This is particularly important when dealing with smaller
customers.
3) Sufficient resources to keep up with cuttingedge know-how and the updating of products in accordance with new know-how.
4) Activities are undertaken to increase the range
of services and resources through either networking or consolidations.
5) Professional business skills are in place for
managing business intelligence, for understanding customer needs, the competition,
risks, for providing effective marketing tools,
and for winning new customers.
Successful companies have typically understood
the importance of serious marketing efforts with
face-to-face contacts in order to acquire international customers. Business growth has been
obtained through consolidations (domestic or
international), by networking with companies
offering synergistic services, or through strategic partnerships. The last alternative was the
strategic choice of a large renowned company
manufacturing active pharmaceutical ingredients.
In addition, the mindset of a successful company
includes the flexibility and sensitivity needed
to adjust the company’s strategy to the rapidly
evolving environment.
4
Contents
1. Introduction
5
2. Contracting of the survey
5
3. Definitions 6
4. Strategic landscape
4.1 Global Venture Capital Funding 4.2 Trends in the pharmaceutical industry affecting
pharmaceutical outsourcing service-providers
4.3 Market for contract research organizations 4.4 Situation on the Finnish market
7
7
7
8
10
5. SWOT analysis
10
6. Results of the survey
6.1 Future prospects of the international service field 6.2 Overview of the services and business arena
6.3 Conclusions based on the i­nterviews conducted
6.3.1. Pharma companies as sponsors
for outsourced services
6.4 Critical success factors for a continuous
customer relationship
12
12
12
16
7. Conclusions
22
8. Selected references
25
9. List of Appendices
Appendix A. Appendix B. Appendix C.
26
26
27
27
16
22
5
1. Introduction
In the first half of the past decade, the Finnish
pharma-related market experienced a major
recession that resulted in bankrupcies, company mergers, and diminished investments in the
pharmaceutical field. A number of surveys conducted since 2005 have highlighted this market
turbulence, the lack of any major recovery, and
the small size of Finnish entrepreneurship in the
pharma-related business. Thus, there are obvious challenges to being successful in this highly
competitive field.
Clinical research organizations (CROs) typically
serve pharmaceutical companies that wish to
perform clinical trials in Finland, taking advantage
of the high quality of the Finnish health care system. The domestic market for contract research
is very limited. Success therefore depends on
international customers, who are not a uniform
group. Some of them are extremely large global
pharma companies while others, such as biotech
companies or even virtual companies, are smaller. Depending on the company type, the needs
and strategies for outsourcing are different.
Vendors in Finland providing services to pharma
customers have previously been surveyed by
Orava and Holopainen (2008). Their study focused on creating a concept for achieving international business or for going international. The
current survey focused on the formation of a holistic view of the pharma related service market
in Finland and on exploration of the future prospects of the international service field, especially
through potential collaboration and networks.
2. Contracting of the survey
The survey was commissioned by Culminatum
Innovation Oy Ltd in 2011 as part of the Verkkovoimaa -project. The aim of the survey was
to create a focused understanding of the needs
and practices/action models of companies that
outsource their work or functions. The goals were
defined as follows:
a. Survey the future prospects of the international service field
b. Create an overview of the business arena and
services in Finland
c. Explore the critical success factors­
for continuous customer relationship
(i.e., repeat business) between the customer
and the service-provider
6
3. Definitions
According to the definition of Orava and Holopainen, the internationalization of a company
means a process during which the company
takes part in international efforts to an increasing extent.
This can be divided into three main
dimensons:
1. International service strategy
2. International operational strategy
3. International market strategy
The core elements of becoming international entail the specification of: 1) what is delivered; 2)
the ways through which the services are made
available on international markets; and 3) the target markets. The internationalization of a serviceprovider is grounded in the business strategy. The
internationalization strategy directs the strategic
choices and defines how the company aims to
become international.
The international service strategy defines the
service offering available to the customer. The
international operational strategy defines the
operational modes through which the company
delivers its services to customers. The international market strategy defines the solution for
the target markets.
The goal of a service strategy is the capability to
compile a competetive service offering for international markets. The operational mode and the
target market solutions define how and where
the service is delivered.
7
4. Strategic landscape
4.1 Global Venture Capital Funding
In the United States, venture capital (VC) funding
shrank from $1.39 billion in 2007 to $688 million
in 2009. The market has recovered since the financial crisis of autumn 2008, but with new rules.
The 20% of US companies that were the most
successful in raising funds garnered 82.6% of VC
fundingin 2010 — up from 78.5% the previous
year and 68.7% in 2005. Conversely, the bottom
20% of companies raised only 0.4% of the VC
funding — down from 0.6% in 2009 (Ernst and
Young, 2012). Even though the overall funding
increased, a growing share of the total was in the
form of large debt financings by mature, profitable companies. While the total capital raised in
the United States increased by 15% in 2010, innovation capital actually declined by 20% over
the same period. “Innovation capital” means total
funding minus large debt financings by mature,
profitable companies. Furthermore, the amount
of money truly available to companies is even
lower. The widespread use of milestone-based
payments may be relatively new in venture funding, but it has long been commonplace in strategic alliances. There are good reasons for the
use of contingency-based payments. The practice
creates a greater incentive for biotech companies
to keep focused on critical milestones. Although
companies have less capital available to them,
they are called on to do more with diminished
resources as the process of discovering and developing drugs becomes increasingly lengthy, expensive, and risky.
Biotech investors large and small — ranging from
venture capitalists to activist public investors —
focus increasingly on mergers and acquisitions as
the most efficient way to capitalize on their holdings. As venture capitalists have to nurture portfolio companies for ever longer periods before
the companies can go public — and are seeing
relatively low public market valuations when the
companies do go public — many of them have
concluded that exit via a trade sale is the only
sensible path. Indeed, many venture capitalists
now have a portion of their portfolios invested
in low-burn-rate “build-to-sell” entities — which
essentially are research projects.
4.2 Trends in the pharmaceutical
industry affecting pharmaceutical
outsourcing service-providers
The advancement of pipelines and the approval
of new products are the tangible milestones of
companies’ R&D efforts and expenditures. New
product approvals decreased industry-wide in
2010 as compared to 2009 and remained at a distressingly low level given the aggregate amount
of R&D investment and the significant unmet
needs of patients. In the absence of new and
better drugs, demographic changes and the increasing incidence of chronic diseases will stretch
government programs and budgets around the
world.
During the last decade, expiring patents have
profoundly influenced the behavior of pharmaceutical companies. Even so, patents expiring
in 2011–2014 will lead to a loss of $82 billion in
pharmaceutical business. At the end of the last
decade, major pharmaceutical companies, impacted by the financial crisis and concerned by
the imminent loss of patent exclusivity on blockbuster products, revised their research and development priorities. In particular, a greater proportion of funding was allocated to products in later
stages of development. Indeed, the number of
FDA drug approvals has declined markedly, from
an average of 36 per year between 1994 and
2004 to an average of 21 per year since 2005.
The patent cliff also prompted big pharmaceutical companies to bolster drug development
pipelines and increase efficiencies through both
mega-mergers and mini-mergers. These takeovers resulted in periods of outsourcing inertia as
integration took place. The merger process also
contributed to the trimming of development
pipelines and reduced the number of pharmaceutical companies both big and small from which
to win business. All these factors have impacted
on service-providers in recent years. At the same
time, service-providers have had to cope with
the withering of biotech business once venture
8
capital funding had dried up. As to CROs as an
investment target for VCs, many VCs typically shy
away from services, the few exceptions being
funds that work in the healthcare service space.
The reason for this is the focus on high growth
in order to to increase the exit values that VCs
need.
4.3 Market for contract research
organizations
The CRO market has grown continuously for
some two decades, especially in clinical services.
In 2010 the market for CROs covering preclinical
through to Phase I to IV clinical trial services grew
16%, to $27 billion. Similarly, the global market
for contract manufacturing organizations (CMO)
was valued at $22.5 billion in 2009. By 2013 it is
predicted that the market will reach nearly $34
billion as biopharmaceutical companies turn to
CMOs for active pharmaceutical ingredients (API),
excipients, formulation services, lyophilization,
and more.
Private equity firms are driving a large proportion
of merger and acquisition activity among small to
medium-sized CROs. At $3.9 billion, PPD was the
largest equity takeover in 2011. In fact, most of
the big CROs are now owned by private equity
firms, which may mean that further consolidation
of the CRO business will occur.
Before the dramatic shift in the biopharmaceutical landscape that occurred at the end of the
decade, some preclinical CROs claim to have
had six-month waiting lists for toxicology work.
Recently with total global capacity at CROs and
biopharmaceutical companies far exceeding demand, prices fell and service-providers faced
pressures to go lower and lower. In spite of this,
preclinical toxicology currently runs at 70% of capacity. Large sponsors do not implement major
changes in their strategies; only a small portion
of toxicology is outsourced. The return of funding
for biotechs, which before the downturn were
vital toxicology clients, will be a key element of
any recovery.
While toxicology continues to face problems,
preclinical CROs can benefit from the imminent
loss of patent exclusivity on the first wave of biologics. To capitalize on this market opportunity,
companies are developing two types of products: attempts at exact copies of the innovator
biologic, called biosimilars; and improvements
over the original molecule, known as biobetters.
Biobetter development in particular requires an
understanding of preclinical toxicology and assay development beyond the skill set of many
pharma companies entering the market.
Drug discovery services are also expected to
perform well. In 2009, Business Insights valued
the market at $7.4 billion but, with the industry
becoming more comfortable with the outsourcing of discovery work, the figure is expected to
rise to $18.5 billion by 2015. However, continued
prioritization of late-stage candidates could make
these growth predictions optimistic. As it stands,
chemistry services account for close to 40% of
the market. Biological services make up 28% of
the market and this share is expected to grow in
the coming years.
Major pharmaceutical companies announced 22
alliances with CROs in the past year. The real figure is greater, as many deals are kept private.
Big companies, in particular, sign strategic partnerships, such as Eli Lilly and Covance: Covance
bought the Greenfield, Indiana site for $50 million. The fee paid by Covance was drafted by an
outsourced business by Lilly, worth $1.6 billion
over 10 years. Another case, that of Sanofi and
Covance, illustrates how a CRO can secure a guaranteed amount of business, tighter links to the
client, and new capabilities. Through the deal
with Sanofi, Covance added chemistry capabilities
and became the sole provider of central laboratory services, adding $1.2 billion to its backlog. In
December 2010, Aesica (a CMO) bought three European production plants from UCB and entered
into a long-term supply agreement as a sign of
more strategic outsourcing relationships. Discussions around deeper, more strategic relationships
are now moving into early phase development,
too. Bristol-Myers Squibb signaled the trend in
August by choosing Icon as one of two preferred
providers in early phase clinical development.
Sponsors increasingly want to perform clinical trials in patients, as opposed to healthy volunteers.
Taking this approach is one part of a strategy designed to get to proof-of-concept as quickly and
efficiently as possible.
9
The wish to secure consistent business from key
clients plays a role in the second trend – consolidation of CMOs. A report by PwC predicted
that consolidation of CMOs will create serviceproviders with the scale and capabilities to support completely outsourced production and distribution networks, a 100% virtual supply chain
(Taylor 2012).
formed more cheaply. Biologics, high potency active pharmaceutical ingredients (HPAPI) and steriles are a few of the areas in which CMOs have
added capabilities. This also reflects the increasing prevalence of these products in the biopharmaceutical development pipeline. However, with
regard to predictions concerning preclinical CROs,
India and China have been disappointments.
The strategic outsourcing trend is driving large
amounts of business to a small group of CROs
that possess the global capabilities required to
handle the late stage needs of leading pharmaceutical companies. Leading CROs are taking
steps across their businesses as they seek to access the knowledge needed to be a true drug
development partner to biopharmaceutical companies without burdening themselves with the
overheads sponsors are shedding by outsourcing.
An April 2011 report by Jefferies & Company predicted that the leading CROs, defined at the time
as Quintiles, Covance, PPD, Parexel, Icon, Charles
River, and Kendle, would account for close to half
of the market by 2014. In 2010 these companies
had 41% of the market. The trend in the pharmaceutical business is cutting the vendor networks
(Taylor 2012).
Strategic decisions in industry seem to take place
slowly. Proponents of outsourcing say pharmaceutical companies would make more efficient
use of resources by closing in-house capacity, thereby eliminating a fixed cost, and using
CROs. This strategic thinking is reflected in the
predicted growth in the turnover of CRO businesses. Progress in implementing this approach,
however, has been slow.
Niche market players will benefit from the increased demand for specialized clinical trial services, particularly in cancer and central nervous
system disorders. With big CROs signing strategic deals and niche players winning business
through specialization, there is a theory that midtier players will be caught between two stools.
The diversity of sponsor sizes is one factor underpinning mid-tier CRO business wins. Data suggest that there is a close association between
the size of a sponsor company and the size of
the clinical service-provider selected to perform
clinical trials. Smaller sponsor companies are best
served by small to medium-sized providers (Taylor, 2012).
Contract manufacturers have also had a challenging few years. Simple, low-margin ingredients
and formulation work moved east, to India and
China in particular, where the work can be per-
4.4 Situation on the Finnish
market
Both the pharma business and the service business have been fairly turbulent in the recent
years. Some 20% of vendors have ceased operations. The domestic market for the vendors
has become largely nonexistent. Success therefore hinges on international customers that are
by no means uniform. Some of the customers
are extremely large and global while others are
smaller, e.g. biotech companies or even virtual
companies. The needs of and strategies in outsourcing services obviously differ depending on
the company type.
Basic research in Finland has been of high quality. Many of the service-providers are spin-offs
from university groups and possess some unique
skills. University departments, however, continue
to provide selected services that compete with
those offered by commercial national serviceproviders.
10
Traditionally, Finland was a preferred location for
conducting clinical trials due to the country’s well
organized health care and highly trained clinical
investigators. This led to the founding of several
clinical CROs. In recent years, however, there has
been a decreasing trend in the volume of clinical trials. The reasons for the decline are manifold and include, e.g. cost level, physicians’ lack
of interest in acting as investigators, a scarcity
of patients and the speed of recruiting patients
for clinical trials. In all of the Nordic countries,
submissions to the regulatory authorities to perform clinical trials have decreased considerably.
Great drops occurred when the EU Directive on
drug trials entered into force in 2004/2005 and
with the economic recession in 2009. In Finland,
submissions of drug trials have decreased by half
in five years’ time, coming to about 200 in 2010
and further declining to 110 commercial submissions in 2011 (and a total of 141). The number of
ongoing trials has diminished by more than one
third, being 340 in 2011. Furthermore, more than
90% of the study subjects in trials are included in
vaccine trials – which indicates the importance of
unique skills and the opportunity of niche players
in the marketplace. Conversely, “bulk trials” are
no longer conducted in Finland.
5. SWOT analysis
SWOT analysis is precented on the following
page.
11
Strengths
Weaknesses
• Finnish basic science continues to be highly
ranked internationally
• Research with long and sound traditions
leads among other things to high-quality
service business with an appreciated core
competence in areas such as vaccine research, carbohydrate research, organic
chemistry in connection with a pharmaceutical background, neurobiology, cardiovascular diseases, and cancer biology
• Tekes funding is available for start-ups and
successful development companies
• CMOs offering biopharmaceuticals and
gene transfer products are located in Finland
• Some Finnish service companies (CROs
and CMOs) have been able to offer unique
services attracting attention even from big
companies
• Some service-providers (based on ingenious skills) with unique services have been
set up and are beginning to prosper
• Investing in professional business skills has
proved successful when in place
• Few big pharma companies have true R&D
activities in Finland
• The number of start-ups in Finland has not
increased markedly during the past decade
• The number of domestic pharma sponsors
outsourcing R&D activities is too small to
support service business
• In Finland, only a few subsidiaries of international pharma companies have maintained a real medical department for interaction specifically in the case of clinical
trials
• Decisions on where clinical trials take place
are taken at the headquarters of pharma
companies or by CROs contracted by these
companies
• Most non-clinical CROs are small whereas
the trend is towards bigger players.
• Comprehensive risk management as well
as business and marketing skills are underdeveloped in small domestic companies
Opportunities
Threats
• Results from basic science continue to produce findings that have business potential
– including the potential for service business
• Networking between companies can create critical mass that will help to win business
• Small sponsors are better served by small
vendors
• Flexibility in adjusting the business strategy
in accordance with global trends
• International visibility achieved through
collaboration
• Strategic partnerships to improve the service portfolio
• Flexible and tailored services entailing special skills to serve niche markets
• Utilization of public sector data warehouses
such as KELA
• Clinical trials in Finland may dry up
• CROs and service business continue to consolidate
• Big and medium-sized pharmaceutical
companies deal only with companies of
the same size
• Small and start-up companies deal with local service companies
• Knowledge of and experience in the pharma business as well as familiarity with their
preferred ways of working are limited, due
to the limited history of the business in Finland
• Strategic partnerships between pharmaceutical companies and vendors may narrow down the “open” CRO market
The items listed in this SWOT analysis are shown in the order of their priority.
12
6. Results of the survey
The survey focused on companies that have a
close relationship with drug development.
vider deals between the parent company and big
pharmaceutical players (Interviews).
6.1 Future prospects of the international service field
6.2 Overview of the services and
business arena
As a whole, both the CRO market and the CMO
market will continue to grow internationally,
since many large to medium-sized biopharmaceutical companies are cutting their in-house assets. The prospects are dimmed by the strategic
deals made between the big CROs and pharmaceutical companies. CROs are thus ensured
a guaranteed amount of business, their links to
clients are tighter, and they acquire new capabilities. Only big CROs are able to make such deals.
About half of the clinical trial work conducted
in Finland is secured by strategic, preferred pro-
Selected company listings and business catalogues were utilized in surveying the business
arena. Furthermore, the websites of the companies identified for the survey were were consulted in order to check and update the information
and service profiles.
In total, 63 companies were identified for inclusion in the survey. Twenty were pharmaceutical
companies and 43 were service-provision companies in seven different areas (Appendix A; Table 1).
Table 1. Service-provision companies by area, ownership,
and competitive situation
Grouping of
service-provision
companies
Bioinformatics
Preclinical CROs
Disease models
APIs/Biological
Statistical services
Clinical CROs
Special services
Total
*4Pharma
Finnish
4
3
1
6
2(3)
6
7
30
Subsdiary of an
international owner
0
1
1
3
(1)*
7
1
13
Competition
within the group
Yes
Yes
No
No
Yes
Yes
No
13
The service-provider field is heterogenous. Companies have apparently tried to specialize so that
they can provide unique services. The competitive situation is the toughest for clinical CROs,
where the market is declining, big international
players have subsidiaries here, and the services offered are practically identical. A number
of companies within the fields of bioinformatics and preclinical CROs offer at least tangential
services.
The size distribution of the companies identified
is presented in Table 2.
Table 2. The size distribution of the companies identified
Business area
Micro
(Personnel
1-9)
Small
(Personnel
10-49)
Medium
(Personnel
> 50)
Service
Pharma
Summary
13
10
23
22
6
28
8
4
12
The medium-sized service-provision companies
were the Systems Biology Worldwide group
(including 4Pharma, Novamass, and Toxis), Cerebricon (part of Charles River), Fermion (large;
a subsidiary of Orion), Galilaeus, PCAS, Medfiles,
Quintiles and Encorium. Only Orion was categorized as large, while Santen, Bayer, and the Finnish Red Cross Blood Service were medium-sized.
In general, the size of the company seems to increase with the time in operation.
The companies were placed into the most appropriate locations in the value chain. The distribution of service-provision companies based on
size and phase of drug development is presented
in Table 3a. A more detailed view is presented in
Table 3b, where the service-provision companies
are grouped on the basis of their core service
area.
Table 3a. Distribution of service-provision companies by headcount and ­location
in the value chain
Phase of
development
Micro
(Personnel
1-9)
Small
(Personnel
10-49)
Medium
(Personnel
> 50)
Discovery
Nonclinical
Phase I
Phase II/III
Different
companies*
8
2
6
4
13
7
10
16
12
22
5
6
5
2
8
*The totals for the different companies by headcount are not the column sums because
many companies are active in multiple fields of drug development.
14
Table 3b. Service-provision companies by core service area
Phase of
development
Micro
(Personnel
1-9)
Small
(Personnel
10-49)
Medium
(Personnel
> 50)
Discovery
- Biology/target
- Screening /Chem
- Disease models
20-22, 124
24, 30,126
130
70,131
41
40
Nonclinical
- ADME
- Toxicology
31
Phase I
91
60,61,90,122,
125, 127
53
101,103,
105,108
32,51,62,81,
102,104,109,
110, 120
50,52,100,
106,107
Phase II/III
Regulatory
32
(32)
121,123
The numbers refer to information in Appendix A. Numbers in bold represent foreign companies.
A few characteristic strongholds were identified
in the Finnish service business arena. All of the
successful companies have long traditions of
top-quality research. Such areas include cardiovascular diseases, cancer biology, chemistry with
a longstanding history in the pharmaceutical environment, unique biopharmaceutical CMOs, a
vaccine research tradition starting in the 1950’s
when pioneering clinical trials on the polio virus vaccine were conducted in Finland, basic research on the role of bacterial polysaccharides in
disease pathogenesis and immunity conducted
at the National Publich Health Institute combined
with a suitable infrastructure (antenatal and
well-baby clinics) and registries. These are the
reasons for the success in attracting global vaccination trials to Finland, and today they account
for the majority of subjects included in clinical
trials in Finland. For decades, carbohydrate chemistry studies were systematically carried out by
a prominent group at University of Helsinki; this
work laid the basis for the success of Glykos Finland. Other high-quality research areas include
neurobiology, encompassing both basic and clinical research as well as product development for
a variety of imaging purposes. The above list is
not conclusive but illustrates the importance of
having a tradition to build on, both for continued
research activity and for spin-offs such as service
business.
15
The total turnover of service-provision companies in 2010 was €162 M, of which Fermion accounted for some €66 M. The other two serviceproviders with a turnover exceeding €10 M were
PCAS and Encorium (together €27.7 M).
The distribution of turnover among service-provision companies is presented in Table 4 (Lith
2012).
Table 4. Distribution of turnover among service-provision companies in 2010
Turnover
Companies
Not
available
<
€100000
€1000001M
€1-5
M
€5-10
M
>
€10 M
N
8
7*
9
12
5#
3
44
*Of the service-providers in this category, Imanext, Genosyst and CNServices no longer exist. The
other companies in this category, being start-ups in 2010, are apparently doing well.
#Glykos Finland has a rapidly increasing turnover; over €6 M by 2010.
The turnover of clinical CRO companies decreased
by more than 25% from 2008 to 2010 (from €55
M in 2008 to €38 M in 2010). Nevertheless, some
clinical CROs, e.g. Medfiles, have managed to increase their business during the same period. At
the same time, the turnover of other serviceprovision companies increased from €19.6 M
to €25.9 M, excluding the incidental increase of
turnover of ARK Therapeutics in 2008 .
Profitability is challenging for companies with
a turnover of less than €5 M because business
development, marketing, and international presence are difficult in such a situation.
16
6.3 Conclusions based on the
­interviews conducted
Interviews were carried out as follows:
Questionnaire for Pharmaceutical outsourcing
vendors (Appendix B)
Questionnaire for Pharma companies ­as sponsors for outsourced services (Appendix C)
6.3.1. Pharma companies as sponsors for outsourced services
6.3.1.1 Potential areas for outsourcing
Outsourcing is highly dependent on the company,
its size, its in-house capabilities, and company
culture.
1) Anything can be outsourced. Certain functions are always outsourced because of a lack
of in-house capability. Other entities are outsourced depending on the in-house resources
that are available.
2) In general, early R&D on proprietary molecules is carried out in-house rather than outsourced, although this is not an absolute rule.
Protection of intellectual property rights influences the outsourcing policy and may rule
out the use of outsourced services.
3) There are big global players that tend not to
outsource any research activities before phase
I because they do not want to reveal the targets they are working on. Such companies
are self-sufficient with regard to most of the
technologies necessary for conducting drug
research, e.g. genomics and bioinformatics.
However, research activities are carried out
with academic institutions, which are the preferred collaborators simply because scientific
excellence is the only thing that matters.
4) Precompetitive research often carried out
through public-private consortia involves
joint activities of academic institutions and
industry. This form of “outsourcing” is under
constant growth (Cain 2012).
6.3.1.2 Outsourcing strategies
Preferred provider agreements
About half of the clinical trial business conducted
by big international CROs is based on preferred
provider agreements. Basically all business that is
directed to Finland takes place by decision of the
parent company. Possible strategic partnerships
or risk sharing issues are not reflected in the operational activities practiced in Finland.
Strategic partnerships are really
strategic issues
Contrary to published information, strategic partnerships are not really practiced by some big
pharmaceutical compnies. On the other hand,
medium-sized pharmaceutical companies are
eager to enter into such agreements.
Risk sharing
Shared responsibility is challenging and is therefore avoided by players big enough to do so.
6.3.1.3 Vendor selection process
In general, companies wish to restrict the number
of CROs to collaborate with. This means that the
vendors they select tend to be larger rather than
smaller in size and are therefore able to provide
an array of services. The reliability and quality of
services, including the economic stability of the
company, are assessed through a lengthy process
involving on-site visits and interviews. The sponsor wants to see references, thereby making sure
that they are not the only customer. Overly small
vendors are considered a risk. A need for truly exceptional expertise may prove to be a reason for
diverging from both of the usual requirements,
namely size and previous experience.
Companies seek vendors with unique skills and
excellence. Mutual trust is the most important
criterion for a continued relationship. Personal
contacts are pivotal to business!
Price plays a role but may not be decisive. Overall
costs count, i.e. the total costs of the outsourced
service and the internal work required to accomplish the task. CROs are assessed regularly and
tendering takes place in order to ensure that the
price level remains at an acceptable level.
A new vendor is seldom selected to provide all of
the required services because of the risk involved
when prior experience of quality, speed, etc. is
lacking. When a new vendor is considered, due diligence is conducted, including the financial status of
the vendor. In most cases, the sponsor team visits
the vendor and the due diligence can be very thorough, going down to inspecting lab notebooks.
17
A commercial company as a vendor may be a
better service-provider option than an academic
group, because universities today are difficult in
terms of getting an agreement. Furthermore,
there may be conflicting interests between internal research activities and service-provision
needs. Companies of one or two persons are seldom chosen as a service-provider because the
deal entails the risk that a person with critical
skills may leave the company, thereby endangering the whole task.
Requirements for making a new or a small company a credible vendor:
• Documentation of the product established
(validated to ensure that the results can be
relied on)
• Certainty for the client that the service will
be delivered as agreed (an established quality management system is a prerequisite for
confidence)
• Prior personal contacts increase credibility
(applies, e.g. to biostatistics services).
• The selected company is recognized as representing excellence in its field (quality scientific publications, cross references by other
known clients, unique and novel features of
the service that make the service more attractive than the standard service)
• References about the service-provider(s)
• Previous positive experience
6.3.1.4 Gaining information about
potential service-providers
• Register of service-providers. It is difficult for
a new vendor to get on the list. The change
of vendor should result in tangible benefits
for the client that make it worth starting the
evaluation process.
• Congresses and exhibitions are the main forum for new contacts. In other words, the
vendor must engage in marketing efforts in
order to be considered as a potential serviceprovider. Many vendors pre-arrange a contact
with the appropriate person at the potential
client organization. All interviewed service
vendors stressed both the importance of being present at commercial congresses and
exhibitions and the need of being very active
even when hunting for potential customers.
• Publications attract the interest of sponsors,
especially when dealing with cutting-edge
research services. Again, it is scientific excellence that is decisive.
• Personal contact(s) are helpful in establishing
initial interest.
6.3.1.5 Services acquired from Finland
Reasons for selecting a Finnish service-provider
• Local and therefore handy
• Good previous experience
• Skills in the Finnish language are required
• Tekes projects may require collaboration with
a defined Finnish vendor
6.3.1.6 Opinion of service-provider
networks
Services offered to pharmaceutical company
through a network of vendors are not considered
attractive because of unclear responsibility issues
and the quantity of legal work. Subcontracting
by a service-provider is acceptable provided that
one of the vendors bears the responsibility for
the services of all vendors (legal, quality, delivery
time). Nevertheless, networking can be the key
to success. Emerging information indicates that
smaller CROs benefit and win business to Finland
through integration into networks (Medfiles).
6.3.1.7 Recommendations of the interviewees to CROs wishing to acquire international
business
1) Share experience and standards of operation
between experienced and inexperienced
vendors
- The clinical CROs in Finland, e.g. Medfiles,
have established a quality system in their
company and have sufficient know-how of
the quality requirements of the pharmaceutical industry. Therefore, their eventual contribution as a partner of an inexperienced
vendor (e.g. one providing discovery research
services) could speed up the vendor’s capability to go global.
- Sharing experience, e.g. by entering into
a partnership, needs to be justified by sound
business (Fermion).
18
2) Make sure that the business is built on solid
core competence and that the competitive
edge is maintained
- There are plenty of CROs selling standard services. The competitive edge depends
on company size and especially on solid core
competence(s) and a unique company and
service portfolio. Niche markets for specialized skills!
3) Networking with other companies providing
synergistic services may be essential for the
success of small companies
- A dynamic network; the service portfolio
should be designed as a collaborative activity, and it should be synergistic and mutually
beneficial to all parties
- Agreement as to who in the network
takes responsibility for the service range acquired by the customer (service sales, delivery conditions, quality, and financial transactions). The consortium needs to speak with
only one voice.
4) Gain marketing muscle one way or a
­ nother
- Strategic partnership with a suitable international network may be a solution for
gaining business (Medfiles’ approach)
6.3.2 Pharmaceutical service-provision companies
There are some 43 service-provision companies
(a small representation of international CRO companies was not included). Thirteen (2 mediumsized, 6 small and 5 micro companies) of the 43
companies were clinical CROs. Size, personnel, or
history is not necessarily reflected in the maturity of operations and the level of professionalism
(Tables 3a & 3b).
The maturity (size, age, and personnel) of a company is partly reflected in its age (Table 5).
19
Table 5. Maturity distribution of service-provision companies
Micro
(Personnel
1-9)
Small
(Personnel
10-49)
<2
1
1
2–5
7
3
>5
5
18
8
13
22
8
Age of service provision companies (yrs)
Summary
Many of the companies are successors to a previous company, e.g.
• Encorium is the successor to Remedium (trade
sale)
• Euformatics is the successor to Medicel (Medicel had ceased operations)
• Admescope is the successor to Novamass (a
new company established on a knowledge
base)
• Systems Biology Worldwide is the successor
to Toxis, Novamass, and 4Pharma (acquisitions)
• Pharmatest is the successor to Dermagene/
Clinixion, Orthotopix, and Genolyze (merger/
fusion)
• Spin-offs from university groups (Pharmatest,
Orthotopix, Novamass, Genolyze) or industry (Remedium, 4Pharma, Statfinn, Cyncron,
Crown CRO, Premedic, Syrinx)
• Some of the companies seemed to have
ceased operations during some 6-month period of the survey; this is a sign of the volatility of the field (GCP tutkimuspalvelu, Imanext,
CNServices, Genosyst, Fatman Biodesign).
6.3.2.1 Customers, marketing,
and markets
Type of customers
The need for services depends on the customer’s
experience and size.
• Big pharmaceutical companies need outsourcing vendors in situations involving lack
of resources, whereas smaller companies are
dependent on the overall know-how a vendor can provide in addition to the acquired
specific service. This is perceived as an opportunity by vendors highly skilled in their area
of expertise (e.g. ADME studies).
Medium
(Personnel
> 50)
• The customers of Finnish vendors are mainly
virtual drug development companies, phytopharma, biotech and medium-sized European pharmaceutical companies. However,
the largest vendors and those providing very
specialized services have been successful in
gaining big pharmaceutical companies as customers. A larger vendor with sufficient service capacity is required when dealing with a
large customer.
Gaining customers
References from big customers that are satisfied with the services received are important
when dealing with smaller customers having
scarce knowledge of the field. Pilot projects are
a functional but not a guaranteed way, even if
successful, of obtaining a customer for repeated
business. The pilot, if run smoothly, is intended
to convince the customer of the entire service
process from purchase to final report.
Identification of the real decision-makers in the
customer companies is an issue and remains a
great challenge.
Universities or university groups usually are not
customers. They are often perceived as competitors.
Marketing muscle is badly needed. Usually this is
a challenge for a small company, especially when
in the initial phase.
Ways for overcoming the issue include:
20
• Consolidation (the trade sale of Remedium
to Encorium; the creation of Systems Biology
Worldwide with strategic acquisition to serve
customers especially in the preclinical arena;
Pharmatest; Cerebricon with the acquisition
of special know-how by Charles River, thereby gaining access to global distribution channels)
• With the exception of the contract manufacturing business, we are not aware of real examples of partnering with a pharma client, a
phenomenon that is increasingly common in
the US.
Dedicated full-time sales personnel and agents
for promoting business are available thus far only
in the largest vendor companies, but smaller vendors are currently investing in dedicated marketing and sales personnel.
6.3.2.2 Defined and conceptualized service
product
The extent to which the company has conceptualized the service product is a key issue for
success irrespective of the service area. Here,
the vendor needs to possess: 1) a high level of
acknowledged expertise in a narrow area; 2)
special skills (plus resources) and dedication to
improve or develop the next generation product
extremely quickly; 3) service-mindedness, entailing flexibility in service-provision with timely
delivery as well as the capability to offer custom
tailored services to customers who need knowhow and support.
The basic issues are a clearly defined product or
service (fact sheet available) and a quality system in place to ensure the repeatability of the
quality of the service product. Furthermore, using
a healthy critical attitude, the vendor company
needs to fully understand its core competence(s),
its competitive edge, and the unique selling
points of its service or product:
• the customer benefits must be formulated
• a unique selling proposition must be formulated
The more mature the vendor was, or the more
industrial experience its key personnel had, the
better the product was standardized and the better the other requirements were in place.
• Room for improvement with some of the
vendors!
Customized products based on a technology platform
An example of a highly specialized product is the
custom tailored R&D collaboration of Glykos with
its pharma clients. Firstly, Glykos Finland represents exceptional skills in carbohydrate chemistry, with expertise that has accumulated over
40 years. Secondly, it is pursuing an aggressive
IP policy possessing more than 45 patent families, and it is actively protecting any new innovations. Thus, their product is a conceptualized R&D
package based on their proprietary technology.
In return, customers are requested to pay royalties on any product entering the market in which
the IP protected technology of Glykos Finland is
utilized. The business model differs from that of
a service-provider because the revenues are not
linearly dependent on the amount of work needed for producing the service.
21
6.3.2.3 Strategy for obtaining
international customers
There is virtually no market for pharma services
in Finland. Therefore, international customers are
a prerequisite for business. Many of the service
companies are small and provide diverse services. However, the possibility of forming strategic
partnerships should be considered so it would
be possible to offer more competitive and comprehensive service packages to international customers. The partnering company obviously does
not need to be Finnish.
Customers are obtained through active marketing and sales efforts as the product or service
has been conceptualized and fulfills the quality
requirements. The success of these activities is
closely related to the strategic choices of the
company and its understanding or creation of its
core competencies.
All outsourcing vendors agreed that successive
commercial exhibitions (expensive!) are essential
for developing international business. In some
cases, scientific publications or congresses are
helpful. Decision-makers regularily visit commercial conferences.
• The active search for customers (electronic
searches; a network of companies revealing potential customers to one another) may
help as preparatory work for conferences
• Try to arrange face-to-face contacts with
decision-makers. As an initial contact, this is
seldom successful since decision-makers are
efficiently protected from these kind of contacts because all service providers are trying
to make contact. Even dedicated consultants
have not been able to make contact.
The following are important additions when securing business
• Web page
• Mass emailing
• Electronic news and letters to customers
• References of important customers
• Repeat business deals obtained through quality; flexibility and appropriate pricing when
tied up with longer-term business deals
• Time is needed; 2–3 years of marketing efforts
6.3.2.4 Networks and strategic
partnerships
Networking with companies providing complementary services are becoming highly important
for business also in Finland. Services are sold by
one of the network participants, who takes responsibility for the entire purchase (legal apects,
quality, delivery terms). A university is not part
of such network because companies are usually
reluctant to buy services from a university. Universities seldom provide timely deliver with sufficient quality and quantity.
Main challenges
• Small vendors face economic challenges in
two critical issues
Partnerships to increase business
Fermion is partnering with an established clinical
research organization providing the active pharmaceutical ingredient (API) for clinical trials managed by the CRO. The partner’s share is in providing the API for preclinical and phase I studies,
whereas Fermion’s share is in phase 2 to phase
3 trials. Fermion’s strength is to produce the API
in sufficient quantity and with sufficient quality
to continue as the API provider when the experimental product has eventually obtained marketing approval. Acting as a CMO was a strategic
decision taken in 2008.
Medfiles is part of a regulanetR network, with
members in over 80 CROs throughout the world,
providing life science services. This allows the establishment of new service packages, e.g. including health economic analyses in the service. Altogether Medfiles is a good example of a company
that continuously develops its business strategy
to reflect the global trends of the field in order
to be successful.
Via strategic partnering, the scope of services can
be widened (as above). This was mentioned as
a strategic aim by several of the vendors interviewed.
22
• Marketing efforts remain modest and insufficient to gain the bulk of new customers
• Development resources are inadequate to
keep up with cutting-edge technology and
thereby to remain competitive
• Change in the global environment (the
number of clinical trials has decreased in Finland)
• Opportunities to find strategic companions
within the service field are perhaps underutilized
• Comprehensive business skills may be lacking, which impacts on risk management, IP
strategy, skills in compiling agreements, sales
strategy, understanding customer needs, and
thus also impacting on the sales package formulated to meet the needs of each individual
customer.
6.4 Critical success factors for a
continuous customer relationship
If the service is based on scientific achievements,
those need to be of top class. Mechanisms need
to be in place to stay level with, or preferably
ahead of, scientific development in the global
field.
• Ability to produce or provide unique services
or services of extremely high quality
• Ability to create or change the market
• Let the customer know that you are committed to achieving the common goal
• Be a trustworthy vendor. If the customer is on
its way to making a mistake, you must have
the courage to advise the customer even if it
jeopardizes the deal
• You have the financial capability to be visible
• Ability to continuously produce value to the
customer without fail.
7. Conclusions
Internationally and in Finland, investment markets are in a downturn, making the acquisition of
funding extremely difficult, especially in Finland.
The pharmaceutical industry as well as the service-provision market is consolidating both horizontally and vertically, making the competition
ever tougher. Both of these main trends make
the international commercialization of services by
Finnish vendors a challenging task. International
commercialization is, however, a necessity since
the home market is unable to support serviceproviders.
Based on the experience obtained in their
project, Orava & Holopainen (2008) divided the
internationalization process of service companies
into three phases: (i) development of the knowledge base; (ii) international commercialization;
and (iii) accelerated growth. The phases were in
relation to the maturity of the products (development of services, definition and formalization of
service products and marketing communication)
and preparedness to go international (especially
the capabilities in and knowledge of international
marketing, resources, and the level of detailed
market information). In general, the later the
phase in which the company was, the higher the
level of the capabilities seems to be.
23
Table 6. The internationalization process of service-provision companies of Finnish
origin as defined by Orava & Holopainen (2008)
Grouping of service-providers of
Finnish origin
N
Bioinformatics
4
Preclinical CROs
3
Disease models
1
APIs/Biological
6
Galilaeus
Macrocrystal
Biovian
2(3)
EPID Research
Statfinn
(4Pharma)
Clinical CROs
5
CRST, Secret files,
Premedic
Clinical Research
Medfiles,
Crown
CRO
Special services
6
Galena,
DRA consulting
DelSiTech,
Syrinx
Zora, CRF
Health
11
10
5
Statistical
services
Total
28
Development of
the knowledge
base
Euformatics,
Genevia
International
commercialization
Initial
Advanced
Xemet
Medisapiens
Neurotar,
Plexpress
Admescope
Accelerated
growth or
established
international
business
Pharmatest
2
The international companies operating in Finland
can be considered to be either in the advanced
international commercialization phase or the accelerated growth phase, meaning that they are
in direct competition with the corresponding
Finnish companies (Table 1).
In terms of products, the suggested means for
becoming international and for reaching accelerated growth include
• ensuring that your perceived competitive
edge is true from a global perspective. Be
critical and honest
• making sure that your skills remain up-todate and your service product remains competitive, being preferrably unique
- The product or service (fact sheet available) should be clearly defined and a quality system should be in place to ensure the
repeatability of the quality of the delivered
Fermion, Pharmatory, Glykos
Finland
service product. Furthermore, using a healthy
critical attitude, the vendor company needs
to fully understand its core competence(s),
its competitive edge, and the unique selling
points of its service or product:
- Customer benefits formulated
- Unique selling proposition
formulated
• In terms of business skills, invest in comprehensive business planning. Researchers are
usually not the best persons for sales or for
planning a business strategy. Use professionals for the purpose.
• be flexible and alert in modifying your business strategy to reflect domestic and global
trends
24
• marketing muscle is required to make yourself visible. The most important is to participate repeatedly in commercial congresses
and exhbitions and even to hunt for customers. One has to be prepared that this phase
may last at least 2–3 years.
- Being content with websites, e-mailings
and newsletters is not the most efficient way
to gain sales. Rather, you should attempt to
understand any customer’s needs individually and to tailor your sales package accordingly. Business intelligence is a prerequisite
for achieving the above.
Finnish-based companies should aim at a preferred provider status and, in some cases, at
strategic partnerships, but risk sharing is almost
beyond the arsenal of Finnish companies (Point
6.3.1.2).
Strategic partnerships may be an efficient way of
widening your service portfolio to meet customer
needs in a competitive way. During recent years,
much consolidation has already taken place to
achieve the needed operative and financial objectives from develoment of the knowledge base
to commercialization (Table 6). In any case, the
general critical success factors need to be taken
into account (Point 6.4). Internationally, strategic
partnerships seem to be the preferred way to
gain growth.
Yet, the interviews indicate that many companies
seem to appreciate independence and tend to
keep customer contacts as an “intellectual prop-
erty” of the company. This may mean that the
companies should be more open to cooperation
to be able jointly to utilize the knowledge and
capabilities of a number of companies instead
of wasting energy on mutual competition (Table
1).
It seems that the companies which are able to
form or participate in networks are successful.
This is supported by the current international
trends in use even by big companies. The resources of small companies are always limited;
this together with the current findings may lead
to the general conclusion that collaboration even
to the extent of losing independence may be the
preferred approach to growth and going international. Another model some smaller companies are employing and moving forward in their
internationalization is to provide really unique
services (Medisapiens, Epid Research and Glykos
Finland).
Orava & Holopainen 2008 proposed the following five internationalization models based on
networking. Examples are presented below:
1. Virtual Hub Organization Model (­ Medfiles)
2. Co-exporting Alliance Model (Fermion)
3. International Integration Model (Systems Biology Worldwide)
4. Global Integration Model (Cerebricon)
5. Sub-contractor Model (Ark)
25
8. Selected references
Biotechnology companies in BioTurku. Catalogue
2010. www.turkusciencepark.com
Brännback M, Jalkanen M, Kurkela K, Soppi E.
Pharma development in Finland today and 2015
(TEKES report 163/2004). Update by M. Jalkanen
& E. Soppi. TEKES report 179/2005
Cain C. A mind for precompetitive collaboration. Science-Business eXchange 2012: 5(19);
doi:10.1038/scibx.2012.483. Published online
May 10, 2012.
Ernst and Young. Beyond borders. Global Biotechnology report 2012biotechnology report 2011
Fimea. Kliinisten lääketutkimusten tilasto 2010 &
2011
Finnish Life Science Organisations. BioFinland catalogue 2011-2012
www.healthbio.fi
Helander I. Steady decline in Nordic countries. Biotech Scandinavia 2011:6:9
Helander I. Collaboration will save Nordic trials.
Biotech Scandinavia 2011:6:8-9
Lith P. Healthbio -alan toimiala- ja suhdannekatsaus 2011 - Tiivistelmä osaamisalan yritystoiminnan laajuudesta, yritysrakenteesta ja taloudellisesta menestyksestä, 2012
Lääketeollisuus. Kliiniset lääketutkimukset. 2011
Orava M, Holopainen J. Lääkealan asiantuntijapalvelusektorin kansainvälistymis-konseptin luominen - ja monistettavuus. Hankkeen loppuraportti.
Maaliskuu 2008
PAREXEL’s Bio/pharmaceutical R & D statistical
sourcebook 2007/2008
Soppi E, Ikonen V. Suuri lääketutkimusselvitys
2006. M.I.T. Consulting Oy 2006.
Soppi E, Ikonen V, Ranki-Pesonen M. Tekes selvitys: Survey of the Finnish subsidiaries of international pharma companies - Pharma- Building
competitive edge. M.I.T. Consulting Oy 2011.
The Swedish Drug Development Pipeline. The
Swedish Life Science Industry Organization.
2010
Taylor N. Optimism returns to pharmaceutical
outsourcing sector. Nature Biotech 2012
26
9. List of Appendices
Appendix A: List of service-providing companies and pharmaceutical companies
Appendix B: Interview questionnaire, Pharma
Appendix C: Interview questionnaire, Service providers
Appendix A. Company listing
Bioinformatics
20
Euformatics Oy
21
MediSapiens Oy
22
Genevia Technologies Oy
23
Xemet Oy
Preclinical CROs
30
PlexPress Oy
31
Admescope Oy
32
Systems Biology Worldwide Oy,
Toxis Ltd Oy
33
Novamass Oy
34
Neurotar Oy
Disease models
40
Charles River Discovery
Research Services Finland Oy
41
Pharmatest Services Oy
APIs / Biologicals
50
Fermion Oy
51
Pharmatory Oy
52
PCAS Finland Oy
53
Galilaeus Oy
60
Biovian Oy
61
Medipolis GMP Oy
62
Ark Therapeutics Oy
70
Glykos Finland Oy
126
Macrocrystal Oy
Statistical services
80
EPID Research Oy
81
StatFinn Oy
82
Oy 4Pharma Ltd
Clinical CROs
90
Clinical Research Services Turku CRST
(Turun yliopisto)
91
GCP Tutkimuspalvelut Oy
100
Quintiles Oy
101
Secret Files Oy
102
TFS Trial Form Support Oy
103
Oy Premedic Clinical Research Ltd
104
Crown CRO Oy
105
Cyncron Oy
106
Encorium Oy
107
Oy Medfiles Ltd
108
NORMA ApS filial i Finland
109
Covance Clinical and Periapproval
Services Limited
110
PAREXEL Finland Oy
Special Services
120
CRF Box Oy
121
DRA Consulting Oy
122
SYRINX Bioanalytics Oy
123
Galena Oy
125
DelSiTech Oy
127
ValiRx Finland Oy
130
Zora Biosciences Oy
131
Computational Medicine Research Group
(Oulun yliopisto)
Vaccine companies - Start up
150 FIT Biotech Oy
151
Vactech Oy
152
Desentum Oy
Pharma companies - Start up
160
Aurealis Oy 161
Faron Pharmaceuticals Oy
162
Hermo Pharma Oy
163
Hormos Medical Oy
164
Medeia Therapeutics Oy
165
Novobion Oy
166
Oy Fennopharma Ltd
170
Biotie Therapies Oyj
171
Laurantis Pharma Oy
172
Vegenics/Circadian
Big Pharma
180
Orion Oyj
181
Bayer Oy
182
Santen Oy
183
Sanquin Oy
184
Finnish Red Cross Blood Service
Viral Therapeutics - Start up
190
Oncos Therapeutics Oy
191
FKD Therapies Oy
27
Appendix B.
Items to be discussed
Potential areas for outsourcing
- areas where outsourcing is
never practiced?
- Outsourcing strategies
- Role of Strategic partnerships
- Risk sharing
General criteria for decision making with
regard to services and service providers
- Common vs Unique Skills
- Personal contacts/Mutual
respect/Distance/Cultural aspects
Gaining information of potential service
providers
- Personal contacts/selling efforts/other
Who is responsible for decision making &
Process in terms of which service provider to
choose?
- Opinion on network by services
providers.
Appendix C.
Kysymykset
1. Yrityksen luonnehdinta
- Yrityksen historia/ ikä
- Toimintaympäristö: suomi;
kansainvälinen
- Suuruus (liikevaihto?)/henkilöstö
- Rahoitustilanne/ kokemus
rahoituksesta/ ongelmat
2. Palvelutuote ja tuotteistus
- miten tuotteistus on tehty?
3. Yrityksen vahvuudet?
- Ydinosaaminen
- Tuotteen Unique selling point /
proposition
- Toiminnan laatutekijät (toiminta­-
ohjeet)
4. Ketkä ovat asiakkaita?
- tutkimusryhmät; yritykset?
- kotimaiset
- ulkomaiset
5. Yrityksen päämarkkinointi/
myyntikeinot?
- Miten viimeiset asiakkaat on saatu?
6. Onnistumiset/ epäonnistumiset
liiketoiminnan luomisessa/markkinointi
fokuksessa
- Halukkuus, mahdollisuudet Strategic partnerships/Risk sharing
- Kun sopimusta ei syntynyt,
mikä mielikuva on miksi ei?
- markkinapenetraation vaatimat
resurssit, kuten osaaminen ja rahoitus
28
- tieto markkinoista,
- asiakkaista,
- kilpailusta,
- yhteistyömahdollisuuksista,
sekä kontaktien löytymiseen
ja kontaktointiin liittyvät asiat,
kuten oikea lähestymistapa ja
kommunikointi.
7. Markkinat (Miten ja mille markkinalle
yritys suuntaa toimintaansa & kansainvälitymisstrategia)
Onko kansainvälistymisstrategia tehty?
- Suunnittelu
- Markkinatutkimusten tekeminen
sisäisesti tai ulkoisena palveluna
- Ulkoisten asiantuntijapalveluiden käyttö
- Tuotteistamiseen liittyvät
toimenpiteet
- Markkina- ja asiakaskartoitusmatkat
eri maissa ja klustereissa
- Osallistuminen messu- ja
partnerointitapahtumiin
Osaaminen; resurssit
Vahvuuksien ja heikkouksien analysointi
- Palveluprosessin arviointi
- Palvelutuotteiden
luominen/täsmentäminen
- Palveluiden hinnoittelu
- Palvelutuotannon tehostaminen
- Uusien näkökulmien löytäminen
- Brandin vahvistaminen
Yhteistyömuotoihin perustuva vai yritysten integraatioon perustuva?
9. Verkostot (yliopisto/yritykset) keiden kanssa yhteistyötä ja keistä olisi selkeää hyötyä
Kokemus yliopistoyhteistyöstä
- mitä tehty; tulos?
- halu jatkaa yhteistyötä/ aloittaa
yhteishankkeita?? Miksi?
Kokemus yhteistoiminnasta
muiden yritysten kanssa
Dynaaminen verkosto (itsenäisten yritysten liitto,
jossa tehdään yhteistyötä valittujen projektien ja
tavoitteiden kautta) vaatii onnistuakseen seuraavia asioita:
- Olemassa oleva tarve
(market opportunity)
- Yhteiset tavoitteet
- Strateginen synergia (ml. palvelu portfoliot ja toimintatavat)
- Yhteistyövalmiudet ja –kyvyt
- Sitoutuminen
Tuotteiden pitäisi muodostaa toisiaan täydentävä
palvelujen ketju, jossa eri yritysten tarjoamat
- palvelutuotekokonaisuudet voidaan muokata yhteiseksi palveluportfolioksi
tuotteistamisprosessin kautta.
- Markkinavalinnat ja operaatio muotovalinnat täytyy saattaa yhden
mukaiseksi ja/tai toisiaan synergis tisesti täydentäviksi.
- Rahoitus ja voitonjaon määritys on
tehtävä sopimuspohjaisesti
Kotimaisia yrityksiä
Kansainvälisiä yrityksiä
Kuinka helppo on asiakkaan päättäjän identifi­
ointi
8. Kilpailutilanne
10. Mitä muuta asiaan liittyvää mitä en ole
osannut käsitellä?